# K133488: Piezomed

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Oct 16, 2014 after 337 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K122322 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122322: Piezosurgery Touch, Mectron S.P.A. (2012) Summary page 4.

## Most influential descendants
- K253776: Implantmed Plus II & Piezomed Plus II Module (2026), 0 descendants of its own

## Indications for use
Piezomed is a piezoelectric ultrasonic device, consisting of handpieces and associated instruments, intended for: - Bone Cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; - Scaling applications, including: o Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; o Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde preparation; o Restorative and Prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.

Source page: https://510kreport.com/device/K133488
Methodology: https://510kreport.com/methodology